| Product NDC: | 12496-0757 |
| Proprietary Name: | Buprenex |
| Non Proprietary Name: | Buprenorphine Hydrochloride |
| Active Ingredient(s): | .3 mg/mL & nbsp; Buprenorphine Hydrochloride |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 12496-0757 |
| Labeler Name: | Reckitt Benckiser Pharmaceuticals Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA018401 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19850630 |
| Package NDC: | 12496-0757-1 |
| Package Description: | 5 AMPULE in 1 CARTON (12496-0757-1) > 1 mL in 1 AMPULE |
| NDC Code | 12496-0757-1 |
| Proprietary Name | Buprenex |
| Package Description | 5 AMPULE in 1 CARTON (12496-0757-1) > 1 mL in 1 AMPULE |
| Product NDC | 12496-0757 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Buprenorphine Hydrochloride |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 19850630 |
| Marketing Category Name | NDA |
| Labeler Name | Reckitt Benckiser Pharmaceuticals Inc |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
| Strength Number | .3 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |